The FDA slapped its highest-risk label on Abbott’s (NYSE:ABT) blood glucose meter recall, deeming the software glitch potentially deadly for patients.
Abbott last month said that it had already issued a free software update to patch the problem, which may affect as many as 50,000 FreeStyle InsuLinx blood glucose meters on the market.
The Chicago-area healthcare giant warned in April that the FreeStyle InsuLinx might display incorrect test results at blood glucose levels of 1024 mg/dL and above, a very rare scenario. Abbott said there had been a single reported "patient incident" involving the glitch, in which the meter may display and store an incorrect test result if the recorded blood glucose is above 1024 mg/dL.
The FDA gave the recall Class I status, usually reserved for "situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death."
No other Abbott blood glucose products have been affected, according to Abbott.